MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-05 for BURETROL SOLUTION SETS EMC9601N manufactured by Baxter Healthcare Corporation.
[182162788]
Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[182162789]
It was reported particulate matter was observed in a buretrol blood administration set. The particulate appeared to be? Piece of paper? Noted "within the buretrol chamber". The issue was noted during priming of the line. Was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2020-01195 |
| MDR Report Key | 9793020 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-02-07 |
| Date Mfgr Received | 2020-02-10 |
| Date Added to Maude | 2020-03-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242702068 |
| Manufacturer G1 | BAXTER HEALTHCARE - TUNISIA |
| Manufacturer Street | ROUTE DE CHEBBAOU 2021OUED E |
| Manufacturer City | TUNIS |
| Manufacturer Country | TS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BURETROL SOLUTION SETS |
| Generic Name | SET, BLOOD TRANSFUSION |
| Product Code | BRZ |
| Date Received | 2020-03-05 |
| Model Number | NA |
| Catalog Number | EMC9601N |
| Lot Number | 19G06T037 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | DEERFIELD IL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-05 |